Otc - Active Ingredient
Active Ingredient
Zinc Oxide 13.5%
Inn Beauty Sun Balm Spf30 Broad Spectrum Lip Balm - Latte Cream
FDA Label NDC 68577-193
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmax Usa, Corporation for the product Inn Beauty Sun Balm Spf30 Broad Spectrum Lip Balm - Latte (NDC 68577-193). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, uses, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Sunscreen
Uses
Uses
- helps protect against sunburn and chapped lips
Otc - Do Not Use
Do not useon damaged or broken skin
Otc - When Using
When using the productkeep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctorif rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control center right away.
Directions
Directions
- apply generously and evenly 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
Sun Protection Measures. Spending time increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures indluding:
Inactive Ingredient
Inactive Ingredients:
Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Microcrystalline Wax, Silica Dimethyl Silylate, Bis-Diglyceryl Polyacyladipate-2, Sorbitan Olivate, Isononyl Isononanoate, Squalane, Simmondsia Chinensis (Jojoba) Seed Oil, Mangifera Indica (Mango) Seed Butter, Butyrospermum Parkiii (Shea) Butter, Tetrahexyldecyl Ascorbate, Rosa Canina Fruit Oil, Bisabolol, Sorbitan Isostearate, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, VP/Hexadecene Copolymer, Dehydroxyacetic Acid, Lecithin, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499), Yellow 5 Lake (CI 19140), Red 7 Lake (CI 15850), Tocopherol, Menthone Glycerin Acetal, Flavor.
Other Information
Other information
- protect this product from excessive heat and direct sun
Package Label.Principal Display Panel
Tube (Sunbalmspf30 Latte Pp)
Carton Side 1 (Innbeauty Carton1)
Carton Side 2 (Innbeauty Carton2)
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